Biden expected to nominate Robert Califf as FDA commissioner

WASHINGTON — President Joe Biden is expected on Friday to nominate Robert Califf to head the Food and Drug Administration, a long-awaited nominee to run an agency key to combating the Covid pandemic, according to people familiar with the process.

Califf, a cardiologist at Duke University who has worked with Google parent company Alphabet, briefly served as FDA commissioner at the end of the Obama administration. He also worked at the agency as deputy commissioner overseeing medical and tobacco products.

Biden waited until the final possible moments to make the nomination — under the federal Vacancies Act the acting commissioner Janet Woodcock would no longer be able to serve in the temporary role as of Monday unless Biden put forward a nominee.

With Democrats holding a razor thin margin in the Senate, Califf could face a difficult nomination process where members could raise a range of issues from his involvement in the private sector to wider issues around drug safety and ties between the FDA and the companies it regulates. Republicans have stalled a number of Biden's nominees across a range of agencies from ambassadors to the Defense Department.

Califf had wide bipartisan support during the Obama administration where he was confirmed by the Senate with a vote of 89 to 4.

The FDA has played a central role in Biden’s response to the pandemic with its oversight of vaccines, tests and treatments. Public health officials have said the uncertainty about who would fill the post has led to instability at the agency.

Among the pressing issues before the FDA are whether to approve new antiviral drugs to treat Covid from Merck and Pfizer and if booster shots of Pfizer’s vaccine should be cleared for use in all adults.

The agency has taken heat over the last year for the length of time it took to give final approval to the Covid vaccines and a controversial approval of an Alzheimer’s drug.

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